NOREPINEPHRINE BITARTRATE
Generic: NOREPINEPHRINE BITARTRATE
Camber PharmaceuticalsManufacturer
INTRAVENOUSRoute
NOREPINEPHRINE BITARTRATEActive Substance
2025-01-31Original Approval
NOREPINEPHRINE BITARTRATE is FDA application ANDA219163, sponsored by ASPIRO. Any recalls listed below come from FDA drug enforcement reports, and reaction counts are the number of FAERS adverse event reports that mention the drug and that reaction; a report does not prove the drug caused it.
Recalls
Class II2024-01-23
Norepinephrine Bitartrate in 5% Dextrose Injection, 8 mg/ 250 mL (32 mcg/mL), For Intravenous Infusion Only, 250 mL vialIncorrect product concentration on the overwrap label: The overwrap label incorrectly identified the
Class III2023-03-29
Norepinephrine Bitartrate Injection, USP, 4 mg/4 mL* (1 mg/mL), 4 mL Single-dose Fliptop Vial (NDC 47335-615-40); packagFailed Impurities/Degradation Specifications: Above the specification limits yielded for related sub
Top Reported Reactions
1
DRUG INEFFECTIVE
422 reports
2
CONDITION AGGRAVATED
310 reports
3
OFF LABEL USE
278 reports
4
HYPOTENSION
275 reports
5
MULTIPLE ORGAN DYSFUNCTION SYNDROME
257 reports
6
SEPSIS
252 reports
7
CARDIOGENIC SHOCK
221 reports
8
STRESS
216 reports
9
GENERAL PHYSICAL HEALTH DETERIORATION
198 reports
10
VOMITING
185 reports